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Not Applicable
Online Mental Health Program for Postpartum Mothers
N/A
Waitlist Available
Led By Lase Ajayi, MD
Research Sponsored by Woebot Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 3 and end of treatment at 8 weeks
Awards & highlights
Study Summary
This trial studied the use of an online mental health program to help postpartum mothers.
Who is the study for?
This trial is for postpartum mothers who are part of the PowerMom study, can read English, and commit to a 16-week program. They must be over 16 years old, within 3 months after giving birth, and have regular access to a recent smartphone with SMS and internet.Check my eligibility
What is being tested?
The W-PPMA intervention is being tested for its practicality and how well it's received by diverse postpartum mothers. The study involves engaging with the program through their smartphones over a period of four months.See study design
What are the potential side effects?
Since this trial tests an app-based intervention rather than medication or medical procedures, traditional side effects are not applicable. However, participants may experience discomfort or stress related to time commitment or content interaction.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 3 and end of treatment at 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 3 and end of treatment at 8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Client Satisfaction Questionnaire (CSQ-8)
Content satisfaction ratings in the W-PPMA application
Number of active days in the W-PPMA application
+4 moreSecondary outcome measures
Edinburgh Prenatal Depression Scale (EPDS)
Generalized Anxiety Disorder Questionnaire (GAD-7)
Patient Health Questionnaire (PHQ-8)
+1 moreOther outcome measures
Feasibility, acceptability, perceptions of stigma as a barrier to mental health care, and mood outcomes across key sociodemographic variables of race and ethnicity, age, and level of education
Mother Infant Bonding Scale (MIBS)
Working Alliance Inventory (WAI-SR)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: W-PPMAExperimental Treatment1 Intervention
Participants randomized to this arm will have access to the W-PPMA mobile app throughout the 16-week study. Participants are asked to use the app for at least 5 minutes a day during the treatment phase (first 8 weeks) and then as often as they like during the follow-up phase (last 8 weeks) of the study.
Group II: WaitlistActive Control1 Intervention
Participants assigned to this group will not have access to the W-PPMA mobile app during the treatment phase (first 8 weeks) of the study. They will have access during the follow-up phase (last 8 weeks) of the study and will be instructed to use the app for at least 5 minutes a day.
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Who is running the clinical trial?
Woebot HealthLead Sponsor
13 Previous Clinical Trials
1,663 Total Patients Enrolled
Scripps Translational Science InstituteOTHER
51 Previous Clinical Trials
579,280 Total Patients Enrolled
Lase Ajayi, MDPrincipal InvestigatorScripps Research Translational Institute
2 Previous Clinical Trials
100,033 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had thoughts of suicide or attempted suicide in the last year.I am 16 years old or older.I can participate and complete tasks for a 16-week study.
Research Study Groups:
This trial has the following groups:- Group 1: W-PPMA
- Group 2: Waitlist
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the upper bound of participants in this experiment?
"Indeed. The clinicaltrials.gov website illustrates that this trial is currently recruiting, with the initial posting occurring on February 22nd 2023 and a subsequent update happening at the same date. A total of 450 participants are needed to be enrolled from 1 particular site."
Answered by AI
Is it possible for individuals to join this scientific experiment voluntarily?
"This clinical trial is actively searching for participants. According to information on the clinicaltrials.gov website, it was initially posted and most recently revised on February 22nd 2023."
Answered by AI
What is the aim of this research endeavor?
"This clinical trial's primary endpoint is to measure the Usage Rating Profile Intervention (URPI)-Acceptability over an 8 week period. Secondary outcomes include Edinburgh Prenatal Depression Scale (EPDS), Generalized Anxiety Disorder Questionnaire (GAD-7) and Perceived Stress Scale (PSS-10). EPDS assesses depression criteria such as emotional numbness, worry and insomnia; GAD-7 evaluates anxious thoughts & behaviours in a two week window; lastly, PSS-10 measures how often situations are appraised as stressful within one month."
Answered by AI
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